BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MICRO-PLATE COTININE EIA

    K Number: K974534 · Decision May 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    6
    Applicant Total
    30
    Review Days
    167

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    Basic Information

    Device Name
    MICRO-PLATE COTININE EIA
    K Number
    K974534
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3220
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    OraSure Technologies, Inc.
    Date Received
    December 2, 1997
    Decision Date
    May 18, 1998
    Product Code
    MKU
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites

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    K020371 UPLINK TEST SYSTEM
    K011057 INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
    K002375 STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
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    K002010 STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
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